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541-0003-00L 2.5 Credits WBZ D-CHAB
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Module 3: Quality and GxP

Lecturers: Prof. Dr. Roger Schibli
Examiners: Prof. Dr. Roger Schibli, Regula Furegati Hafner
Does not take place this semester. Only for CAS in Pharmaceuticals. The enrolment is done by the CAS in Pharmaceuticals study administration.
VVZ CR n/a

Last Updated: 2026-06-01 11:33:08

Abstract

Students learn about pharmaceutical regulations in Switzerland, EU and US, various quality systems and CAPA, quality risk management, life cycle management, quality assurance of biotechnological processis, process validation, quality by design, statistical tools in QA, computerized systems validation, quality aspects of packaging and the role of the qualified person.

Objective

• Quality Risk Management • Quality Systems and CAPA • Pharmaceutical Regulations, Swissmedic and ICH Basics • GMP and its Legal Basis • US Regulations and Enforcement Systems • GxP Requirements with Focus on Distribution • Change Mangement, Life Cycle Mangement • Case Studies for Analytics and Production • QA of Biotechnological Processes • Quality Aspects of Therapeutic Antibodies • Workshop: How to write an effective SOP • Process Validation with Examples • Quality by Design • Statistical Tools in QA • Challenges and Trends in QA • Computerized Systems Validation • Quality Aspects of Packaging • The Role of the Qualified Person

General Information

Language
English
Levels
WBZ
Frequency
Every two years

Examination

Type
ungraded semester performance

Course Components

Type Title Time & Place Hours
lecture with exercise Module 3: Quality and GxP
Does not take place this semester. Block course
No time listed 40 h semesterly

Offered In